References : 1. LYMPHOSEEK Injection [prescribing information]. Dublin, OH: Cardinal Health; June 2017. 2. Sondak V, King DW, Zager JS, et al. Combined analysis of Phase III trials evaluating Tc99m tilmanocept and vital blue dye for identification of sentinel lymph nodes in clinically node-negative cutaneous melanoma. Ann Surg Oncol . 2013;20:680-8. 3. Wallace AM, Han LK, Povoski SP, et al. Comparative evaluation of [99mTc] tilmanocept for sentinel lymph node mapping in breast cancer patients: results of two Phase 3 trials. Ann Surg Oncol . 2013; doi /s10434-013-2887-8. 4. Vera, DR, Tokin CA. Tilmanocept: a synthetic receptor-targeted molecule for sentinel lymph node mapping. International Atomic Energy Agency (IAEA) Publication 2014; Chapter X: In Press.
FYCOMPA caused dose-dependent increases in somnolence and fatigue-related events. Somnolence was reported in 16% and 18% of patients in the partial-onset seizure trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 7% of placebo-treated patients. Fatigue-related events were reported in 12% and 15% of patients in the partial-onset seizure trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 5% of placebo-treated patients. These adverse reactions occurred mostly during the titration phase. These adverse reactions were also observed in the PGTC seizure clinical trial. Patients should be advised against engaging in hazardous activities requiring mental alertness, such as operating motor vehicles or dangerous machinery, until the effect of FYCOMPA is known.